Study identification

EU PAS number

EUPAS34663

Study ID

35329

Official title and acronym

Pharmacological risk factors for COVID-19 infection: a matched prospective cohort study of patients in primary care

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Background: There has been speculation that drugs used to manage chronic conditions such as type 2 diabetes and hypertension could lead to increased risk of both COVID-19 infection and deaths related to the infection. On the other hand there is also belief that some medications may be protective (e.g. HCQ). This has been amplified on social media and there is no current evidence to support these hypotheses. In order to provide appropriate guidance for these high risk patients, it is essential that we conduct a pharmaco-epidemiological study to investigate these effects.Aim: This study will aim to identify the effect of current use of various antihypertensive treatments (ACE inhibitors, ARAs and calcium channel blockers), therapies for type 2 diabetes (SGLT2 inhibitors), NSAIDs and hydroxychloroquine on COVID-19 infection rates and related mortality. We will compare the rates and severity (hospitalisation due to COVID-19, mortality) of COVID-19 infection among patients prescribed with the above-mentioned drugs (with an underlying condition indicating a necessity for their prescription) compared to propensity score matched patients prescribed with comparator drugs (with the same underlying condition). Design: Propensity score matched cohort study with active comparators. Target population: Adults aged 50 years and above with a diagnosis of hypertension, type 2 diabetes mellitus, rheumatoid arthritis and osteoarthritis as of 30th Jan 2020. Outcomes: (1) Composite of confirmed, suspected or probable diagnosis of COVID-19(2) Confirmed diagnosis of COVID-19 (3) COVID-19 associated mortality(4) Hospitalization due to COVID-19

Study status

Ongoing
Research institutions and networks

Institutions

Institute of Applied Health Research

Contact details

Nirantharakumar Krishnarajah

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

TBC
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable